The objective of this study is to determine the dose response relationship regarding blood loss, PK, PD and clinical outcomes of MDCO-2010 in comparison to placebo and tranexamic acid in patients undergoing primary cardiac surgery with cardiopulmonary bypass. The aim of the study is to define minimally effective dose of MDCO-2010.

MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010.

Drug: Tranexamic Acid

Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.

Device: saline

A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. The flow rates will be the same as for MDCO-2010.

Study Arm (s)

Experimental: MDCO-2010

Intervention: Drug: MDCO-2010

Active Comparator: tranexamic acid

Intervention: Drug: Tranexamic Acid

Placebo Comparator: Saline

Intervention: Device: saline

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Men, aged 18 to 85 years, or Women, aged 18 to 85 years, either of postmenopausal status, defined as ≥1 year since last menstrual period AND if less than 65 years old with a negative pre-operative pregnancy test within 24 hours of surgery OR with medical history of hysterectomy or bilateral oophorectomy

Written informed consent

Exclusion Criteria:

Off-pump surgery or hybrid procedures

Patients undergoing repeat sternotomy

Planned deep hypothermic circulatory arrest (<28°C)

Known allergy, sensitivity, or contraindications to tranexamic acid

Epileptiform disorders, history of seizure activity, or anticonvulsive medication

Administration of clopidogrel, ticagrelor or ticlopidine within 5 days prior to surgery or prasugrel within 7 days prior to surgery.

Known history of thrombophilia, such as AT-III, Protein C or Protein S deficiency, Factor V Leiden, anti-phospholipid syndrome

Active liver disease defined as any known current infectious, neoplastic or metabolic pathology of the liver OR ALT or AST elevation >2x ULN or total bilirubin elevation >1.5x ULN at Screening

Any condition requiring ongoing chronic immunosuppressive medication

Malignancy within 5 years prior to surgery

Receipt of an investigational drug or device within 60 days prior to surgery Any other condition which, in the opinion of the Principal Investigator, would put the subject at increased risk from participating in the study or otherwise prevent a patient‟s participation in the study